Phase 2 Study of Temozolomide in Pre-Selected Advanced Aerodigestive Tract Cancers (Study P04273AM2)(TERMINATED)

This study has been terminated.

Sponsor:

Information provided by:

Schering-Plough

ClinicalTrials.gov Identifier:

NCT00423150

First received: November 30, 2006

Last updated: September 23, 2010

Last verified: September 2010

History of Changes

Tracking Information
First Received Date ^ICMJE	November 30, 2006
Last Updated Date	September 23, 2010
Start Date ^ICMJE	January 2007
Primary Completion Date	June 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: September 23, 2010)	Tumor Responses (Complete and Partial Response) [ Time Frame: From start of treatment until participant's disease progression, intolerable toxicity or death, which ever comes first ] [ Designated as safety issue: No ] Tumor response rate was based on Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00423150 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Phase 2 Study of Temozolomide in Pre-Selected Advanced Aerodigestive Tract Cancers (Study P04273AM2)(TERMINATED)
Official Title ^ICMJE	A Phase 2 Study of Temozolomide (SCH 52365) in Subjects With Advanced Aerodigestive Tract Cancers Selected for Methylation of O6-Methyl-Guanine-DNA Methyltransferase (MGMT) Promoter
Brief Summary	This study is proposed to evaluate the efficacy and safety of temozolomide, an oral anti-cancer agent, in a participant population selected for a biomarker. Participants with colorectal cancer, non-small-cell lung cancer, head and neck cancer, or esophageal cancer will be included.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Colorectal Neoplasm Head and Neck Neoplasm Carcinoma, Non-Small-Cell Lung Esophageal Neoplasm
Intervention ^ICMJE	Drug: Temozolomide Temozolomide capsules 150 mg/m^2 daily on a 7-day on / 7-day off schedule for each 28-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent. Other Name: Temodal, TMZ, SCH 52365
Study Arm (s)	Experimental: Temozolomide Intervention: Drug: Temozolomide
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Enrollment ^ICMJE	86
Completion Date	June 2009
Primary Completion Date	June 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Participants must be at least 18 years of age. Participants must have metastatic colorectal cancer (CRC), recurrent or metastatic head & neck (H&N) or esophageal cancer, or locally advanced, inoperable, or metastatic non-small cell lung cancer (NSCLC). Participants must have a tumor sample or a blood sample tested positive for the presence of the biomarker. Participants may have up to 3 prior regimens for CRC, up to 3 prior regimens for NSCLC, up to 2 prior regimens for H&N and esophageal cancer. Participants must have at least one measurable lesion. Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. Participants must have adequate hematologic, renal, and liver functions. Participants must be able to take the study medication capsules orally, or through a feeding tube without the capsules being opened. Participants of childbearing potential must agree to use a medically accepted method of contraception. Exclusion Criteria: Participants who have received treatment for a second malignancy within 1 year before screening, and are considered to be at risk of relapse within 1 year after screening. Participants with unstable or progressing central nervous system (CNS) metastasis. Participants with known CNS metastasis may be included if a) the subject is asymptomatic, b) there is no requirement for steroids or antiseizure medications, or the required doses are stable, and c) there is no associated midline shift or (in the opinion of the investigator) significant edema. Participants who received prior temozolomide or dacarbazine treatment
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00423150
Other Study ID Numbers ^ICMJE	P04273
Has Data Monitoring Committee	No
Responsible Party	Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
Study Sponsor ^ICMJE	Schering-Plough
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Schering-Plough
Verification Date	September 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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